Product code HOZ
- Device name
- Sponge, Ophthalmic
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.4790
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K132796 | SUNTOUCH EYE SPEAR | Huizhou Foryou Medical Devices Co., Ltd. | 2013-10-30 |
| K130117 | NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS | Network Medical Products, Ltd. | 2013-10-29 |
| K091240 | ALPHAMED SURGICAL SPEAR, MODEL 70-5000 | Alphamed, Inc. | 2009-10-23 |
| K082460 | CENEFOM PVA SURGICAL SPEAR | Longtek Scientific Co., Ltd. | 2008-12-15 |
| K012196 | ULTRACELL ABSORBENT STICK | Ultracell Medical Technologies, Inc. | 2001-08-24 |
| K011191 | MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES | Medtronic Xomed, Inc. | 2001-06-26 |
| K003842 | PRESCOTT'S SURGICAL SPEAR | Prescott'S, Inc. | 2001-04-13 |
| K002279 | ML EYE SPEAR, MODEL ML 27 ES | Med-Logics, Inc. | 2000-08-18 |
| K993883 | M-PACT CORNEAL LIGHT SHIELD | M-Pact Corp. | 1999-12-21 |
| K990671 | DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPE | Hurricane Medical | 1999-05-10 |
| K990749 | SOF-SUCTION FLUID EVACUATION SYSTEM | X-Tech Medical, LLC | 1999-04-02 |
| K982599 | THE FREMSTAD RING | Ophthalmic Solutions, LLC | 1999-02-16 |
| K974313 | HYDROFERA SURGICAL SPEAR | Hydrofera, LLC | 1998-03-02 |
| K972633 | ULTRACELL SUCTION SPONGE | Ultracell Medical Technologies, Inc. | 1997-12-17 |
| K972693 | DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR | Deroyal Industries, Inc. | 1997-09-30 |
| K971832 | IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK | M-Pact Worldwide Management Corp. | 1997-07-31 |
| K964855 | EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD | Shippert Medical Technologies Corp. | 1997-03-04 |
| K946016 | IVALON OPHTHALMIC SPONGE | Ivalon | 1995-03-22 |
| K950241 | OPHTHALMIC SPONGES | Oasis Medical, Inc. | 1995-02-27 |
| K942642 | SURGI-WIPE | Surgin Surgical Instrumentation, Inc. | 1994-07-15 |
| K933872 | VISI-SPEAR EYE SPONGE | Visitec Co. | 1993-12-27 |
| K923922 | SURGICAL SPEARS | Ultracell Medical Technologies, Inc. | 1993-03-19 |
| K920354 | OPHTHALMIC SPONGES | Ultracell Medical Technologies, Inc. | 1992-08-05 |
| K910707 | OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS | Jedmed Instrument Co. | 1991-04-10 |
| K902750 | VISI-SWAB OPHTALMIC SPONGE | Visitec Co. | 1990-07-26 |
| K900786 | VISI-SORB ABSORBANT STICK | Visitec Co. | 1990-05-18 |
| K897034 | K-SPONGE | Katena Products, Inc. | 1990-02-15 |
| K896705 | VISITEC MICRO-SPONGE SPEARS | Visitec Co. | 1990-01-11 |
| K896004 | ALCON SURGICAL SPONGE | Alcon Laboratories | 1989-11-02 |
| K896084 | MICROSPEARS | Sparta Surgical Corp. | 1989-11-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10385640090015 | Walcott | Summit Medical, Inc. | 2026-02-03 |
| 30385640090019 | Walcott | Summit Medical, Inc. | 2026-02-03 |
| 10385640090008 | Walcott | Summit Medical, Inc. | 2026-02-03 |
| 16931918190563 | Beaver Visitec Inter | GRI Medical & Electronic Technology Co., Ltd. | 2022-12-13 |
| 16931918185361 | Beaver Visitec Inter | GRI Medical & Electronic Technology Co., Ltd. | 2022-12-13 |
| 16931918117898 | Beaver Visitec Inter | GRI Medical & Electronic Technology Co., Ltd. | 2022-12-13 |
| 16931918195308 | Beaver Visitec Inter | GRI Medical & Electronic Technology Co., Ltd. | 2022-12-12 |
| 10810003224412 | Pro-Paks | MICROSPECIALITIES, INC. | 2022-12-11 |
| M75294300 | STRADIS HEALTHCARE | STRADIS MEDICAL, LLC | 2022-05-17 |
| M75260070IWBULK0 | Stradis Medical, LLC. | STRADIS MEDICAL, LLC | 2022-05-12 |
| M75260071IWSBULK0 | Stradis Medical, LLC. | STRADIS MEDICAL, LLC | 2022-05-12 |
| 20749915002566 | Ophthalmic Pledget | AMERICAN SURGICAL COMPANY, LLC | 2019-07-18 |
| 10810003220100 | PRO-PAKS®️ | MICROSPECIALITIES, INC. | 2019-01-03 |
| 10810003220063 | PRO-PAKS®️ | MICROSPECIALITIES, INC. | 2018-10-30 |
| 10810003220070 | PRO-PAKS®️ | MICROSPECIALITIES, INC. | 2018-10-30 |
| 10810003220087 | PRO-PAKS®️ | MICROSPECIALITIES, INC. | 2018-10-30 |
| 10810003220094 | PRO-PAKS®️ | MICROSPECIALITIES, INC. | 2018-10-30 |
| 10810003220018 | PRO-PAKS®️ | MICROSPECIALITIES, INC. | 2018-10-30 |
| 10810003220056 | PRO-PAKS®️ | MICROSPECIALITIES, INC. | 2018-10-30 |
| 10810003220049 | PRO-PAKS®️ | MICROSPECIALITIES, INC. | 2018-10-30 |
| 10810003220032 | PRO-PAKS®️ | MICROSPECIALITIES, INC. | 2018-10-30 |
| 10810003220025 | PRO-PAKS®️ | MICROSPECIALITIES, INC. | 2018-10-30 |
| 10845819000165 | SOFT CELL® PVA Foam Surgical Spears | OASIS MEDICAL, INC. | 2018-01-09 |
| 10665973017768 | Dukal | Dukal LLC | 2016-12-02 |
| 10852171007831 | Atlanta Healthcare Services OcuDrape® | ATLANTA HEALTHCARE SERVICES, INC. | 2016-11-14 |
| 30634303800213 | FABCO | FIRST AID BANDAGE CO INC | 2016-11-01 |
| 30634303800220 | FABCO | FIRST AID BANDAGE CO INC | 2016-11-01 |
| 30634303800251 | FABCO | FIRST AID BANDAGE CO INC | 2016-11-01 |
| 30634303800268 | FABCO | FIRST AID BANDAGE CO INC | 2016-11-01 |
| 30634303800275 | FABCO | FIRST AID BANDAGE CO INC | 2016-11-01 |